Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

This is a multicenter prospective observational study aimed at evaluating the role of an ultrasonographic score in monitoring disease activity in patients with Takayasu arteritis (TAK). Patients with active disease, either at new diagnosis or during relapse, will undergo serial vascular US assessments during follow-up according to routine clinical practice at each participating centers. For each patient, an OMERACT-derived US score (OTUS) will be calculated. This score was developed and preliminarily validated in previous phases of a multistep project endorsed by OMERACT (Outcome Measures in Rheumatology), an international initiative focused on the development and validation of outcome measures in rheumatology. The study hypothesis is that this score is sensitive to change over time and can be used to monitor disease activity and predict outcome in patients with TAK.

Eligibility criteria

Qualifiers

Age ≥18 years

Male and female

Diagnosis of TAK according to the 1990 ACR and/or 2022 ACR/EULAR classification criteria

Clinical domain: new onset or worsening of clinical signs and/or symptoms attributable to TAK;

Disqualifiers

Inability or contraindication to undergo vascular US

Severe comorbidities limiting participation or follow-up

Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation)

Diagnosis of another rheumatologic disease

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

This trial has no locations

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Collaborator

University Hospital Padova

Collaborator